Eisai and Purdue Pharma Announce Oral Presentation of Latest Clinical and Non-Clinical Data on Lemborexant at 43rd Annual Meeting of the Japanese Society of Sleep Research

TOKYO and STAMFORD, Conn., July 2, 2018 /PRNewswire/ -- Eisai Co., Ltd. (CEO: Haruo Naito, "Eisai") and Purdue Pharma L.P. (President and CEO: Craig Landau, MD "Purdue Pharma") today announced that they will present data on their investigational sleep-wake regulation agent lemborexant (development code: E2006), in an oral presentation at the 43rd Annual Meeting of the Japanese Society of Sleep Research (JSSR), July 11-13, Sapporo, Japan. The presentation will focus on the latest lemborexant data from both clinical and non-clinical studies relating to insomnia, a sleep-wake disorder.

Eisai will present results of SUNRISE 1, a placebo-controlled, double-blind active comparator Phase 3 pivotal study of the safety and efficacy of lemborexant versus placebo and versus an active comparator (zolpidem tartrate extended release, "zolpidem ER") in approximately 1,000 patients 55 years and older with insomnia. Topline results of SUNRISE 1 were announced earlier this year.

"With a robust polysomnography data set, SUNRISE 1 is the first-ever Phase 3 study with a direct head-to-head comparison versus zolpidem ER," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "Our aspiration for lemborexant is to bring patients with sleep disorders a treatment option for sleep-wake regulation that improves their ability to fall asleep and stay asleep, without impairing them the next morning."

SUNRISE 1 evaluated change from baseline for both sleep onset (primary objective) defined by latency to persistent sleep (LPS) and sleep maintenance variables (key secondary objectives), including the time spent awake in the second half of the night. The study used objective polysomnography (PSG) to determine if lemborexant 5 mg and 10 mg had a shorter time to sleep onset and prolonged sleep maintenance compared to the recommended dose of zolpidem ER. It also assessed the ability to maintain postural stability – a predictor of risk for falls – and cognition the next morning. In this study, lemborexant had rates of discontinuation due to adverse events (AEs) comparable to placebo, and the most common AEs in the lemborexant arms were headache and somnolence.

These data build on growing clinical evidence for lemborexant, including two, key Phase 1 studies (Study 108 and Study 106) which were recently presented at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018) meeting.

"The ability to fall asleep quickly and sleep throughout the night and to awake without meaningful residual effects is important for overall health and well-being, and we are pleased to be part of the development of a new potential treatment that makes a difference for people with insomnia," said Marcelo Bigal, MD, PhD, Chief Medical Officer, Purdue Pharma. "In collaboration with our partners at Eisai, we're looking forward to announcing additional near-term milestones for lemborexant."

Non-clinical research data from the course of discovery of lemborexant, including medicinal chemistry and pharmacological evaluation, will also be presented at the meeting.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.

Lemborexant acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli. Through research and development on lemborexant, Eisai and Purdue Pharma are striving to bring a new option for sleep-wake disorders to patients and their families.

Discovered by Eisai, lemborexant is being jointly developed by Eisai and Purdue Pharma. Information about ongoing clinical studies is available at clinicaltrials.gov.

<Notes to editors>

1. About Lemborexant
   Lemborexant, an investigational dual orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule compound which inhibits orexin neurotransmission by binding competitively to two subtypes of orexin receptors (orexin receptor 1 and 2). In individuals with sleep-wake disorders, it is possible that the orexin system which regulates sleep and wakefulness is not functioning normally. During normal periods of sleep, orexin system activity is suppressed, suggesting it is possible to purposefully counteract inappropriate wakefulness and facilitate the initiation and maintenance of sleep by interfering with orexin neurotransmission. Therefore, Eisai and Purdue Pharma have been developing lemborexant as a potential treatment for multiple sleep disorders.
   
   A Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder (ISWRD) and mild to moderate Alzheimer's dementia is underway. Lemborexant is the only sleep-wake agent being studied for ISWRD.
                                                                                       
2. About SUNRISE 1 (Study 304)
   SUNRISE 1 is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of the efficacy and safety of lemborexant in approximately 1,000 patients 55 years and older (45 percent of all patients were aged 65 years and older) with insomnia disorder conducted in North America and Europe. In this study, patients were administered placebo or one of three treatment regimens (lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg), and the primary endpoint was change from baseline in latency to persistent sleep of both lemborexant doses compared to placebo. Key secondary endpoints included change from baseline in sleep efficiency for both lemborexant doses compared to placebo, wake after sleep onset (WASO) for both lemborexant doses compared to placebo, and WASO in the second half of the night (WASO2H) for both lemborexant doses compared to zolpidem ER, after one month of treatment, measured objectively by polysomnography.
                                                                                       
3. About Sleep Disorders
   Population studies show that sleep disorders affect many more people worldwide than previously thought. Insomnia disorder is characterized by difficulty falling sleep, staying asleep or both, despite an adequate opportunity to sleep, that can lead to daytime consequences such as fatigue, difficulty concentrating and irritability. Insomnia disorder is the most common sleep disorder, with persistent insomnia symptoms experienced by approximately 10 percent of the adult population.
   
   Sleeping well is essential for good health, including brain health. Poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.
   
   Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality. Studies suggest an optimal sleep duration between seven and eight hours. Women are 1.4 times more likely than men to suffer from insomnia.
   
   Older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking and early waking, that can lead to less sleep time.
                                                     
4. About Eisai Inc.
   At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
   
   Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities.
   
   Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
                                                                                   
5. About Purdue Pharma L.P.
   Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. For more information, please visit www.purduepharma.com.

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